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United States · US · US:0054-3630_ce07dc5c-441e-4f1c-a940-077306017c43
Naproxen
Orange BookUNIISPLATC G02CC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110054363063500 mL in 1 BOTTLE, PLASTIC (0054-3630-63)
Annotations
UNII (FDA Substance ID)
57Y76R9ATQ
NAPROXEN
RxCUI 7258
Orange Book
A074190
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "57Y76R9ATQ",
"rxcui": "7258",
"inchikey": "CMWTZPSULFXXJA-VIFPVBQESA-N",
"display_name": "NAPROXEN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c5146d73-2f34-4dfe-ac29-97071279dc4d": {
"match": "brand_token",
"title": "NAPROXEN SODIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
"spl_version": "10",
"published_date": "2026-05-28"
}
},
"productid": "0054-3630_ce07dc5c-441e-4f1c-a940-077306017c43",
"productndc": "0054-3630",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "074190",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "25MG/ML",
"product_no": "001",
"approval_date": "Mar 30, 1994"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NAPROXEN",
"proprietary_name": "Naproxen",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA074190",
"marketing_category": "ANDA",
"nonproprietary_name": "Naproxen",
"start_marketing_date": "20210224",
"active_numerator_strength": "125"
}Related drugs
Other records sharing ATC code G02CC02.
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